# K151311: Safe Block Pen Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Artsana S.P.A
- Decided: Feb 10, 2016 after 268 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951254 (1995). 4 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051783: Artsana Pen Needles, Artsana Injection Needles, Artsana S.P.A (2005) Summary page 5.
- K050106: Novofine Autocover 30G X 8MM, Novo Nordisk, Inc. (2005) Summary page 5.

## Most influential descendants
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (2017), 9 descendants of its own
- K210059: Promisemed Insulin Pen Needle (2021), 1 descendant of its own
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle (2021), 1 descendant of its own
- K191853: Dual-Safety Pen Needle (2019), 1 descendant of its own
- K261829: Profoject™ Dual-Safety Pen Needles (2026), 0 descendants of its own

## Indications for use
Safe Block Pen Needle is intended for use with pen injector devices for the injection of fluids, including insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental sticks from the patient end of the needle. The shield also serves to conceal the needle before and after injection.

Source page: https://510kreport.com/device/K151311
Methodology: https://510kreport.com/methodology